Company history

Oncopeptides AB was formed in 2000 to develop anti-cancer drugs based on research by some of Sweden’s leading cancer researchers and cancer research institutions.

The focus of Oncopeptides’ current development, melflufen (Ygalo®), is a result of work originally undertaken by Dr Joachim Gullbo at Uppsala University, Sweden, and in particular his development of a molecule that was first known as ‘J1’ and later as melflufen.

Backed initially by funding from one of Sweden’s leading venture capital firms, Industrifonden, and the development arm of the Karolinska Institutet, Oncopeptides embarked on the pre-clinical development stages.

Following an early study into the effectiveness of ‘J1’ in solid tumours, further work resulted in the molecule that is now melflufen. During this period, Oncopeptides also established a research collaboration with the Harvard Medical School – Dana Farber Cancer Institute in the USA.

Oncopeptides was then able to embark on the Phase 1 and Phase 2 clinical trials of melflufen in late-stage multiple myeloma patients. These studies were financed by Healthcap, a life sciences venture capital fund, and Industrifonden together with participation by the Chairman of the Board and the CEO.

In 2015 following the completion of Phase 1 of the Phase 1/2 study, melflufen was granted Orphan Drug Designation by both the US and EU regulatory authorities, the benefits of which include extended exclusive marketing rights.

There was an intensification of Oncopeptides clinical research and regulatory engagement in 2016. The Phase 2 element of the Phase 1/2 study was presented to the European Hematology Association and several productive meetings were held with the US Food and Drug Administration (FDA) and European authorities.

In the course of 2016, the detailed design of the melflufen Phase 3 study was approved through the US FDA’s Special Protocol Assessment process, which if the study achieves its statistical targets, will lead to marketing approval.

Timeline

2000

Oncopeptides AB was founded to further develop drug candidates, including the future melflufen

Melflufen was patented

2003-2009

Pre-clinical development stage, funded by Industrifonden and Karolinska Development AB

2009-2011

Phase 1 study in solid tumours conducted with Akademiska sjukhuset in Uppsala, Sweden, as lead hospital

2010-2011

Development of pharmaceutical formulation as melflufen has shown instability in its original liquid format

New melflufen freeze-dried pharmaceutical formulation developed and patented

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